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Stockholm3 Validation Study in a Multi-Ethnic Cohort (SEPTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04583072
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
University of Illinois at Chicago
UroPartners
University of Chicago
Information provided by (Responsible Party):
Henrik Grönberg, Karolinska Institutet

Brief Summary:

1.0 Project Summary:

Introduction: Prostate cancer (PCa) is the most commonly detected cancer in men and is the second leading cause of cancer death. Differences in race and ethnicity have been shown to have differences in PCa incidence, detection, and outcomes. Current prostate cancer screening involves prostatic specific antigen (PSA) which is a nonspecific protein marker (aka kallikrein) that can often leads to unnecessary biopsies (up to 74% benign biopsies) and clinical overdiagnosis (with up to 22% clinically insignificant cancer). Recently more sophisticated tests have been developed for PCa screening in the United States such as the Prostate Health Index (PHI) and the 4k (kallikrein) score, as well as clinical models that use information from the patient clinical history. However, these tests utilize limited serum protein assays and none of the established screening protocols utilize genetic variables to help account for the likely inherited risks as seen in different ethnicities.

A recent Swedish, prospective, population-based study, published in the Lancet Oncology, developed a unique multivariable biopsy outcome prediction model within a Nordic population of nearly 60,000 men. This model, the Stockholm3, which incorporated plasma protein markers, germline DNA SNPs as well as clinical variables, was shown to be capable of reducing the number of biopsies by 44% compared to PSA while maintaining adequate sensitivity for detection of PCa.

It is unknown whether an approach developed in Sweden that incorporates protein markers, genetics, clinical variables, and genetic ancestry would be beneficial in a racially diverse cohort.

Hypothesis: The investigators hypothesize that, a prospectively studied multiethnic cohort of men with the Stockholm3 test will identify unique and common risk factors that improve prostate cancer detection.

Aim: To assess the performance of the Stockholm3 test as compared to PSA and to identify unique features associated with PCa in Black (n=500), Asian (n=500), White Hispanic (n=500), and White Non-Hispanic (n=500) men.

Methods: The investigators propose a prospectively identified cohort with participating institutions which have screened positive to undergo a prostate biopsy to have a retrospective analysis the Stockholm3 test and ancestry markers. Within this cohort the investigators will examine several predetermined risk factors to investigate their relationship to prostate cancer.

This blood sample will be tested for quantitative levels of serum protein markers and DNA will be extracted and will be tested for germline mutations as defined by the Stockholm3 test and other ancestry informative markers. Results from the study will be presented in such a way that no individual information will be disclosed.


Condition or disease Intervention/treatment
Prostate Cancer (Diagnosis) Diagnostic Test: The Stockholm3 test

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SEPTA Trial: Stockholm3 Validation Study in a Multi-Ethnic Cohort for ProsTAte Cancer
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Non-Hispanic White men
Self-identified as White Non-Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Diagnostic Test: The Stockholm3 test
Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 ml tubes will be removed after obtaining consent from the subjects.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers

African/Black men
Self-identified as African or Black men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Diagnostic Test: The Stockholm3 test
Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 ml tubes will be removed after obtaining consent from the subjects.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers

Hispanic White men
Self-identified as White Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Diagnostic Test: The Stockholm3 test
Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 ml tubes will be removed after obtaining consent from the subjects.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers

Asian men
Self-identified as Asian men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Diagnostic Test: The Stockholm3 test
Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 ml tubes will be removed after obtaining consent from the subjects.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers




Primary Outcome Measures :
  1. Gleason Grade Group 2 Prostate Cancer [ Time Frame: On prostate biopsy immediately following PSA ]
    International Society of Urological Pathology Gleason Grade Group 2 Prostate Cancer. Gleason Grade Group scale is used to grade prostate cancer if found on a scale from 1 to 5. A higher score means a worse outcome.


Secondary Outcome Measures :
  1. National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk prostate cancer or higher risk [ Time Frame: On prostate biopsy immediately following PSA ]
    National Comprehensive Cancer Network Unfavorable intermediate risk prostate cancer or higher risk. National Comprehensive Cancer Network risk stratification scores range from very low risk, low risk, intermediate risk, high risk and very high risk. Intermediate risk is stratified into favorable intermediate risk and unfavorable intermediate risk. The higher the risk the worse the outcome


Biospecimen Retention:   Samples With DNA
Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 milliliters (8 milliliters total) tubes will be removed after obtaining consent from the subjects. One tube will be immediately centrifuged (10 minutes at 2000G) and plasma decanted to a tube without additives (this typically produces approximately 1.5 milliliters of plasma). The decanted tube (with plasma) and the remaining EDTA tube (with whole blood) is then frozen and stored at -20 degrees Celsius until being shipped to the A23 lab for Stockholm3 testing and analysis at -20 degrees Celsius (unless processing for DNA extraction and plasma analysis).


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biologic XY sex
Sampling Method:   Probability Sample
Study Population
The subjects will be consented for prostate biopsy as part of standard of care. No additional advertising will be used for enrollment. Patients will be identified in clinic which meet the above inclusion criteria for prostate biopsy as part of routine practice. Enrollment will start from date of IRB approval and continue until study enrollment goal. Study enrollment goal will be 2,000 men who have a self-described race/ethnicity of: African/Black (n=500), Asian (n=500), Hispanic White (n=500), and Non-Hispanic White (n=500) men.
Criteria

Inclusion Criteria:

  • Men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
  • Meeting standard of practice clinical criteria for a prostate biopsy. Able to obtain informed consent

Exclusion Criteria:

  • There are no specific exclusion criteria. If there is a paucity of data with regards to the defined variables being analyzed, those patients might be excluded from sub analyses but not all.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583072


Contacts
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Contact: Hari T Vigneswaran, MD +1-708-769-3443 hari.vigneswaran@ki.se
Contact: Ola Steinberg +46-70-377-1897 ola.steinberg@omsab.com

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Michael R Abern, MD       mabern1@uic.edu   
Contact: Ruben Sauer calvo, MD       rsauer1@UIC.EDU   
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Scott Eggener, MD       seggener@surgery.bsd.uchicago.edu   
Uropartners Recruiting
Westchester, Illinois, United States, 60154
Contact: Paul Yonover, MD       pyonover@uropartners.com   
Contact: Celeste Ruiz       CRuiz@uropartners.com   
Sponsors and Collaborators
Karolinska Institutet
University of Illinois at Chicago
UroPartners
University of Chicago
Investigators
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Principal Investigator: Henrik Grönberg, MD, PhD Karolinska Institutet
Publications:

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Responsible Party: Henrik Grönberg, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04583072    
Other Study ID Numbers: KarolinskaI3
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases